Short‐course oral steroids alone for chronic rhinosinusitis

Karen Head; Lee Yee Chong; Claire Hopkins; Carl Philpott; Martin J Burton; Anne GM Schilder

doi:10.1002/14651858.CD011991.pub2

Short‐course oral steroids alone for chronic rhinosinusitis

Appendices

Appendix 1. Search strategies

CENTRAL	Ovid MEDLINE
#1 MeSH descriptor: [Sinusitis] explode all trees #2 MeSH descriptor: [Rhinitis] this term only #3 MeSH descriptor: [Rhinitis, Atrophic] this term only #4 MeSH descriptor: [Rhinitis, Vasomotor] this term only #5 MeSH descriptor: [Paranasal Sinus Diseases] this term only #6 MeSH descriptor: [Paranasal Sinuses] explode all trees #7 rhinosinusitis or nasosinusitis or pansinusitis or ethmoiditis or sphenoiditis #8 kartagener* near syndrome* #9 inflamm* near sinus* #10 (maxilla* or frontal) near sinus #11 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 #12 MeSH descriptor: [Chronic Disease] explode all trees #13 MeSH descriptor: [Recurrence] explode all trees #14 chronic or persis* or recurrent* #15 #12 or #13 or #14 #16 #11 and #15 #17 CRSsNP #18 (sinusitis or rhinitis) near (chronic or persis* or recurrent) #19 #16 or #17 or #18 #20 MeSH descriptor: [Nasal Polyps] explode all trees #21 MeSH descriptor: [Nose] explode all trees #22 MeSH descriptor: [Nose Diseases] explode all trees #23 #21 or #22 #24 MeSH descriptor: [Polyps] explode all trees #25 #23 and #24 #26 (nose or nasal or rhino or rhinitis or sinus* or sinonasal) near (papilloma* or polyp) #27 rhinopolyp or CRSwNP #28 #19 or #20 or #25 or #26 or #27 #29 MeSH descriptor: [Steroids] explode all trees #30 MeSH descriptor: [Adrenal Cortex Hormones] explode all trees #31 MeSH descriptor: [Glucocorticoids] explode all trees #32 MeSH descriptor: [Anti‐Inflammatory Agents] explode all trees #33 MeSH descriptor: [Anti‐Inflammatory Agents, Non‐Steroidal] explode all trees #34 #32 not #33 #35 steroid* or glucocorticoid* or corticosteroid* or glucosteroid* or cyclocosteroid* #36 beclomethasone or beclometasone or beclamet or beclocort or becotide #37 betamethasone or betadexamethasone or flubenisolone or celeston* or cellestoderm or betnelan or oradexon #38 dexamethasoneor dexameth or dexone or dexametasone or decadron or dexasone or hexadecadron or hexadrol or methylfluorprednisolone or millicorten #39 flunisolide or fluticasone or hydrocortisone or cortisol or cortifair or cortril or hyrocortone or cortef or epicortisol or efcortesol or Cortisone #40 methylprednisolone or medrol or metripred or urbason #41 mometasone or prednisolone or precortisyl or deltacortril or deltastab or prednesol or deltasone or prednisone or cortan or liquid next pred or meticorten #42 paramethasone or triamcinolone or aristocort or volon or atolone or kenacort or orasone or panasol or prednicen #43 corticoid* or betamethason* or betamethasone or hydrocortison* or celesto* or dexamethason* or hexadecadrol or budesonid* or horacort or pulmicort or rhinocort or methylfluorprednisolone or flunisolid* or nasalide or fluticason* or flonase or flounce or mometason* or nasonex or triamclinolon* or nasacort or tri next nasal or aristocort or Ciclesonide #44 #29 or #30 or #31 or #34 or #35 or #36 or #37 or #38 or #39 or #40 or #41 or #42 or #43 #45 #28 and #44	1 exp Sinusitis/ 2 paranasal sinus diseases/ or rhinitis/ or rhinitis, atrophic/ or rhinitis, vasomotor/ 3 exp Paranasal Sinuses/ 4 (rhinosinusitis or nasosinusitis or pansinusitis or ethmoiditis or sphenoiditis).ab,ti. 5 (kartagener* adj3 syndrome).ab,ti. 6 (inflamm adj5 sinus).ab,ti. 7 ((maxilla or frontal) adj3 sinus).ab,ti. 8 1 or 2 or 3 or 4 or 5 or 6 or 7 9 exp chronic disease/ 10 exp Recurrence/ 11 (chronic or persis* or recurrent).ab,ti. 12 9 or 10 or 11 13 8 and 12 14 CRSsNP.ab,ti. 15 ((sinusitis or rhinitis) adj3 (chronic or persis or recurrent)).ab,ti. 16 13 or 14 or 15 17 exp Nasal Polyps/ 18 exp Nose/ or exp Nose Diseases/ 19 exp Polyps/ 20 18 and 19 21 ((nose or nasal or rhino or rhinitis or sinus* or sinonasal) adj3 (papilloma* or polyp)).ab,ti. 22 (rhinopolyp or CRSwNP).ab,ti. 23 16 or 17 or 20 or 21 or 22 24 exp Steroids/ 25 exp Adrenal Cortex Hormones/ 26 exp Glucocorticoids/ 27 exp Anti‐Inflammatory Agents/ 28 exp Anti‐Inflammatory Agents, Non‐Steroidal/ 29 27 not 28 30 (steroid* or glucocorticoid* or corticosteroid* or glucosteroid* or cyclocosteroid* orbeclomethasone or beclometasone or beclamet or beclocort or becotide or betamethasone or betadexamethasone or flubenisolone or celeston* or cellestoderm or betnelan or oradexon or dexamethasone or dexameth or dexone or dexametasone or decadron or dexasone or hexadecadron or hexadrol or methylfluorprednisolone or millicorten or flunisolide or fluticasone or hydrocortisone or cortisol or cortifair or cortril or hyrocortone or cortef or epicortisol or efcortesol or Cortisone or methylprednisolone or medrol or metripred or urbason or mometasone or prednisolone or precortisyl or deltacortril or deltastab or prednesol or deltasone or prednisone or cortan or liquid next pred or meticorten or paramethasone or triamcinolone or aristocort or volon or atolone or kenacort or orasone or panasol or prednicen).ab,ti. 31 (corticoid* or betamethason* or betamethasone or hydrocortison* or celesto* or dexamethason* or hexadecadrol or budesonid* or horacort or pulmicort or rhinocort or methylfluorprednisolone or flunisolid* or nasalide or fluticason* or flonase or flounce or mometason* or nasonex or triamclinolon* or nasacort or (tri adj3 nasal) or aristocort or Ciclesonide).ab,ti. 32 24 or 25 or 26 or 29 or 30 or 31 33 23 and 32
Ovid EMBASE	Trial registries (via CRS)
1 exp sinusitis/ or paranasal sinus disease/ 2 atrophic rhinitis/ or chronic rhinitis/ or rhinosinusitis/ or vasomotor rhinitis/ 3 exp paranasal sinus/ 4 (rhinosinusitis or nasosinusitis or pansinusitis or ethmoiditis or sphenoiditis).tw. 5 (kartagener* adj3 syndrome).tw. 6 (inflamm adj5 sinus).tw. 7 ((maxilla or frontal) adj3 sinus).tw. 8 1 or 2 or 3 or 4 or 5 or 6 or 7 9 exp chronic disease/ 10 exp recurrent disease/ 11 (chronic or persis* or recurrent).tw. 12 9 or 10 or 11 13 8 and 12 14 CRSsNP.tw. 15 ((sinusitis or rhinitis) adj3 (chronic or persis or recurrent)).tw. 16 13 or 14 or 15 17 exp nose polyp/ 18 exp nose disease/ or exp nose/ 19 exp polyp/ 20 18 and 19 21 ((nose or nasal or rhino or rhinitis or sinus* or sinonasal) adj3 (papilloma* or polyp)).tw. 22 (rhinopolyp or CRSwNP).tw. 23 16 or 17 or 20 or 21 or 22 24 exp corticosteroid/ 25 exp steroid/ 26 exp antiinflammatory agent/ 27 exp nonsteroid antiinflammatory agent/ 28 26 not 27 29 (steroid or glucocorticoid* or corticosteroid* or glucosteroid* or cyclocosteroid* or beclomethasone or beclometasone or beclamet or beclocort or becotide or betamethasone or betadexamethasone or flubenisolone or celeston* or cellestoderm or betnelan or oradexon or dexamethasone or dexameth or dexone or dexametasone or decadron or dexasone or hexadecadron or hexadrol or methylfluorprednisolone or millicorten or flunisolide or fluticasone or hydrocortisone or cortisol or cortifair or cortril or hyrocortone or cortef or epicortisol or efcortesol or Cortisone or methylprednisolone or medrol or metripred or urbason or mometasone or prednisolone or precortisyl or deltacortril or deltastab or prednesol or deltasone or prednisone or cortan or liquid next pred or meticorten or paramethasone or triamcinolone or aristocort or volon or atolone or kenacort or orasone or panasol or prednicen).tw. 30 24 or 28 or 29 31 23 and 30	ClinicalTrials.gov Condition: rhinitis OR sinusitis OR rhinosinusitis OR (nose AND polyp) OR (nasal AND polyp) OR CRSsNP OR CRSwNP OR CRS ICTRP Title: rhinitis OR sinusitis OR rhinosinusitis OR CRSsNP OR CRSwNP OR CR OR All: (nose AND polyp) OR (nasal AND polyp) NB These searches were run from 1 March 2015 to 11 August 2015, when these terms were last searched to populate the Cochrane ENT trials register in CRS

Appendix 2. Data extraction form

REF ID:	Study title:
Date of extraction:	Extracted by:

General comments/notes (internal for discussion):

Flow chart of trial
	Group A (Intervention)	Group B (Comparison)
No. of people screened
No. of participants randomised ‐ all
No. randomised to each group
No. receiving treatment as allocated
No. not receiving treatment as allocated ‐ Reason 1 ‐ Reason 2
No. dropped out (no follow‐up data for any outcome available)
No. excluded from analysis¹ (for all outcomes) ‐ Reason 1 ‐ Reason 2
¹This should be the people who received the treatment and were therefore not considered 'drop‐outs' but were excluded from all analyses (e.g. because the data could not be interpreted or the outcome was not recorded for some reason).

Information to go into 'Characteristics of included studies' table
Methods	X arm, double/single/non‐blinded, [multicentre] parallel‐group/cross‐over/cluster‐RCT, with x duration of treatment and x duration of follow‐up
Participants	Location: country, no of sites etc. Setting of recruitment and treatment: Sample size: Number randomised: x in intervention, y in comparison Number completed: x in intervention, y in comparison Participant (baseline) characteristics: Age: Gender: Main diagnosis: [as stated in paper] Polyps status: x % with polyps/no information [add info on mean polyps score if available] Previous sinus surgery status: [x% with previous surgery] Previous courses of steroids: [add info on mean number of courses if available] Other important effect modifiers, if applicable (e.g. aspirin sensitivity, comorbidities of asthma): Inclusion criteria:[state diagnostic criteria used for CRS, polyps score if available] Exclusion criteria:
Interventions	Intervention (n = x): drug name, method of administration, dose per day/frequency of administration, duration of treatment Comparator group (n = y): Use of additional interventions (common to both treatment arms):
Outcomes	Outcomes of interest in the review: Primary outcomes: Health‐related quality of life, disease‐specific Disease severity symptom score Significant adverse effects: [review specific] Secondary outcomes: Health‐related quality of life, generic [Other review specific, pre‐specified adverse events] [Other review specific, pre‐specified adverse events] Endoscopy (polyps size or overall score) CT scan Other outcomes reported by the study: [List outcomes reported but not of interest to the review]
Funding sources	'No information provided'/'None declared'/State source of funding
Declarations of interest	'No information provided'/'None declared'/State conflict
Notes

Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)		Quote: "…" Comment:
Allocation concealment (selection bias)		Quote: "…" Comment:
Blinding of participants and personnel (performance bias)		Quote: "…" Comment:
Blinding of outcome assessment (detection bias)		Quote: "…" Comment:
Incomplete outcome data (attrition bias)		Quote: "…" Comment:
Selective reporting (reporting bias)		Quote: "…" Comment:
Other bias (see section 8.15) Insensitive/non‐validated instrument?		Quote: "…" Comment:
Other bias (see section 8.15)		Quote: "…" Comment:

Findings of study: continuous outcomes
Results (continuous data table)
Outcome	Group A			Group B			Other summary stats/Notes
	Mean	SD	N	Mean	SD	N	Mean difference (95% CI), P values etc.
Disease‐specific HRQL (instrument name/range) Time point:
Generic HRQL (instrument name/range) Time point:
Symptom score (overall) (instrument name/range) Time point:
Added total ‐ if scores reported separately for each symptom (range) Time point:
Nasal blockage/obstruction/congestion (instrument name/range)
Nasal discharge (instrument name/range)
Facial pain/pressure (instrument name/range)
Smell (reduction) (instrument name/range)
Headache (instrument name/range)
Cough (in children) (instrument name/range)
Polyp size (instrument name/range)
CT score (instrument name/range)
Comments:

Results (dichotomous data table)
Outcome	Applicable review/intervention	Group A		Group B		Other summary stats/notes
		No. of people with events	No. of people analysed	No. of people with events	No. of people analysed	P values, RR (95% CI), OR (95% CI)
Epistaxis/nose bleed	INCS Saline irrigation
Local irritation (sore throat, oral thrush, discomfort)	INCS Saline irrigation
Osteoporosis (minimum 6 months)	INCS
Stunted growth (children, minimum 6 months)	INCS					Can also be measured as average height
Mood disturbances	OCS
Gastrointestinal disturbances (diarrhoea, nausea, vomiting, stomach irritation)	OCS Antibiotics
Insomnia	OCS
Osteoporosis (minimum 6 months)	INCS OCS
Discomfort	Saline irrigation
Suspected allergic reaction (rash or skin irritation)	Antibiotics
Anaphylaxis or other serious allergic reactions such as Stevens‐Johnson	Antibiotics
Comments:

Appendix 3. EPOS 2012 diagnostic criteria

Clinical definition of rhinosinusitis in adults

Chronic rhinosinusitis, with or without nasal polyps, in adults is defined as:

inflammation of the nose and the paranasal sinuses characterised by two or more symptoms, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip);
± facial pain/pressure;
± reduction or loss of sense of smell.

for ≥12 weeks.

This should be supported by demonstrable disease.

Either endoscopic signs of:

nasal polyps; and/or
mucopurulent discharge primarily from middle meatus; and/or
oedema/mucosal obstruction primarily in middle meatus;

and/or

CT changes:
- mucosal changes within the ostiomeatal complex and/or sinuses.

Clinical definition of rhinosinusitis in children

Paediatric rhinosinusitis is defined as: inflammation of the nose and the paranasal sinuses characterised by two or more symptoms, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/ posterior nasal drip):

± facial pain/pressure;
± cough;

and either endoscopic signs of:

nasal polyps; and/or
mucopurulent discharge primarily from middle meatus; and/or
oedema/mucosal obstruction primarily in middle meatus;

and/or

CT changes:
- mucosal changes within the ostiomeatal complex and/ or sinuses.

Appendix 4. Nasal polyp grading scales

Grade	Ecevit 2015	Lildholdt scale: Alobid 2014 ; Benitez 2006 ; Vaidyanathan 2011	Van Zele 2010	Kirtsreesakul 2012
0	No polyps	No nasal polyps	No polyps	No polyps
1	Mild polyposis (small polyps not reaching the upper edge of the inferior turbinate)	Small polyps confined to the middle meatus	Small polyps in the middle meatus not reaching below the inferior border of the middle concha	Mild polyposis (small polyps, extending downward from the upper nasal cavity but not below the upper edge of the inferior turbinate, causing only slight obstruction)
2	Moderate polyposis (medium polyps between the upper and lower edges of the inferior turbinate)	Moderate sized polyps not crossing the lower edge of the inferior turbinate	Polyps reaching below the lower border of the middle turbinate	Moderate polyposis (medium sized polyps, extending downward from the upper nasal cavity and reaching between the upper and lower edges of the inferior turbinate, causing troublesome obstruction)
3	Severe polyposis (large polyps reaching the lower edge of the inferior turbinate, polyps from posterior ethmoidal sinuses, or both)	Large polyps crossing the lower edge of the inferior turbinate	Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha	Severe polyposis (large‐sized polyps, extending downward from the upper nasal cavity and reaching below the lower edge of the inferior turbinate, causing total or almost total obstruction)
4	—	—	Large polyps causing almost complete congestion/obstruction of the inferior meatus	—

Figure 1

Process for sifting search results and selecting studies for inclusion.

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Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 4

Forest plot of comparison: 1 Oral steroids versus no treatment/placebo, outcome: 1.1 Disease‐specific health‐related quality of life ‐ no pooling (2 to 3 weeks).

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Figure 5

Forest plot of comparison: 1 Oral steroids versus no treatment/placebo, outcome: 1.3 Disease severity (patient‐reported total symptom score).

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Analysis 1.1

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 1 Disease‐specific health‐related quality of life ‐ no pooling (2 to 3 weeks).

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Analysis 1.2

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 2 Disease‐specific health‐related quality of life ‐ RQLQ (3 to 6 months).

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Analysis 1.3

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 3 Disease severity (patient‐reported total symptom score).

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Analysis 1.4

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 4 Individual symptoms: nasal obstruction (final value).

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Analysis 1.5

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 5 Individual symptoms: nasal obstruction (change from baseline).

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Analysis 1.6

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 6 Individual symptoms: nasal discharge (final value).

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Analysis 1.7

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 7 Individual symptoms: nasal discharge (change from baseline).

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Analysis 1.8

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 8 Individual symptoms: facial pressure (final value).

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Analysis 1.9

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 9 Individual symptoms: facial pressure (change from baseline).

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Analysis 1.10

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 10 Individual symptoms: loss of sense of smell (final value).

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Analysis 1.11

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 11 Individual symptoms: loss of sense of smell (change from baseline).

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Analysis 1.12

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 12 Adverse events ‐ significant mood disturbance.

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Analysis 1.13

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 13 Adverse events ‐ gastrointestinal disturbance.

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Analysis 1.14

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 14 Adverse events ‐ insomnia.

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Analysis 1.15

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 15 Endoscopy score ‐ nasal polyps (final value).

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Analysis 1.16

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 16 Endoscopy score ‐ nasal polyps score (change from baseline).

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Summary of findings for the main comparison. Short‐course oral corticosteroids compared with placebo/no treatment for chronic rhinosinusitis

Short‐course oral corticosteroids compared with placebo/no treatment for chronic rhinosinusitis
Patient or population: chronic rhinosinusitis with nasal polyps Intervention: short‐course oral corticosteroids Comparison: placebo/no treatment
Outcomes № of participants (studies)	Relative effect (95% CI)	*Anticipated absolute effects^ (95% CI)**			Quality	What happens
		Without oral steroids	With oral steroids	Difference
Disease‐specific health‐related quality of life measured by severity score of RSOM‐31 (unclear range) Follow‐up: 2 weeks № of participants: 40 (1 RCT)	—	Not estimable	—	The mean disease‐specific health‐related quality of life in the intervention group was 1.24 standard deviations lower (1.92 lower to 0.56 lower)	⊕⊕⊝⊝ LOW ¹	A lower score indicates reduced impairment. Treatment effect in favour of short‐course oral steroids. A SMD of 1.24 is considered a large effect size.
Disease severity, as measured by patient‐reported symptom score, measured by combining 4 individual symptoms № of participants: 22 (1 RCT) № of participants: 114 (1 RCT) № of participants: 114 (1 RCT)	—	—	—	The mean final symptom score² in the intervention group at 17 days was 2.84 standard deviations lower (4.00 lower to 1.59 lower) The change from baseline in symptom score⁷ in the intervention group at 2 weeks was 2.28 standard deviations lower (2.76 lower to 1.80 lower) The change from baseline in symptoms score⁷ at 3 months⁸ was 0.22 standard deviations lower (0.59 lower to 0.15 higher)	⊕⊕⊝⊝ LOW ³ ⊕⊕⊝⊝ LOW ⁹ ⊕⊕⊝⊝ LOW ¹⁰	A lower score indicates milder symptoms in favour of short‐course oral steroids. SMDs of 2.84 and 2.28 are considered to be large effect sizes. Patients treated with oral steroids probably had much milder symptoms at 2 to 3 weeks. A SMD of 0.22 is considered to be a small effect size. Patients treated with oral steroids and then intranasal steroids were probably not much different in their change in symptoms from baseline to 3 months than the patients who received placebo and then intranasal steroids.
Adverse events: significant mood disturbance Follow‐up: 2 weeks № of participants: 40 (1 RCT)	RR 2.50 (0.55 to 11.41)	Study population			⊕⊕⊝⊝ LOW ⁴	It is uncertain whether there were more mood disturbance adverse events in the oral corticosteroids group.
		100 per 1000	250 per 1000 (55 to 1000)	150 more per 1000 (45 fewer to 1041 more)
Health‐related quality of life, using generic quality of life scores	This outcome was not reported in any of the studies
Adverse events: gastrointestinal disturbance Follow‐up: 3 months № of participants:187 (3 RCTs)	RR 3.45 (1.11 to 10.78)	Study population			⊕⊕⊝⊝ LOW ⁵	There were more gastrointestinal disturbance adverse events in the oral corticosteroids group.
		47 per 1000	160 per 1000 (52 to 501)	114 more per 1000 (5 more to 455 more)
Adverse events: insomnia Follow‐up: 3 months № of participants:187 (3 RCTs)	RR 3.63 (1.10 to 11.95)	Study population			⊕⊕⊝⊝ LOW ⁶	There were more insomnia adverse events in the oral corticosteroids group.
		23 per 1000	84 per 1000 (26 to 278)	61 more per 1000 (2 more to 255 more)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial; RR: risk ratio; RSOM‐31: Rhinosinusitis Outcome Measures‐31; SMD: standard mean difference
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹Downgraded to low quality due to limitations in study methodology and imprecision. Only the disease severity scale of the RSOM‐31 was used (unknown validity of this subscale and the range of scores is unclear). One small study (n = 40), which lacked information about the method of randomisation and allocation concealment. There is a also concern that the magnitude of improvement is not sustained; one study that used a non‐validated instrument reported smaller benefit at three to six months than at two to three weeks for health‐related quality of life. ²The individual symptoms measured were: nasal obstruction, nasal discharge, sense of smell and pressure over the sinuses. Scores for the individual symptoms (0 to 10 visual analogue scale (VAS)) were summed to find the total score.The effect size could be underestimated with this method. ³Downgraded to low quality due to imprecision. Results are from one very small study (n = 22) and the results were only measured at the end of treatment (17 days). There is a concern that the magnitude of improvement is not sustained. The outcome was not measured using a validated tool. ⁴Downgraded to low quality due to limitations in study methodology and imprecision. One small study (n = 40), which lacked information about the method of randomisation and allocation concealment. The definition of 'mood disturbance' is not provided in the paper. The results have large confidence intervals. ⁵Downgraded to low quality due to inconsistency and imprecision. The terminology between the papers for this outcome differed from "diarrhoea/GI disturbance" to "gastrointestinal disturbance" to "reflux and/or gastric pain". A low number of events were reported resulting in large confidence intervals. ⁶Downgraded to low quality due to inconsistency and imprecision. The definition of 'insomnia' is not provided in the papers. A low number of events were reported resulting in large confidence intervals. ⁷The individual symptoms measured were: blocked nose, rhinorrhoea, hyposmia and sinonasal pain. The results were measured as individual symptoms on a seven‐point Likert scale (0 = no symptoms) and presented as percentage change from baseline for each symptom, which was averaged across the four symptoms to create an average change from baseline. The effect size could be underestimated with this method. ⁸All patients in both groups received intranasal steroids at the end of the treatment period until the end of follow‐up (12 weeks). ⁹Downgraded to low quality due to limitations in study methodology and imprecision. Results are from one small study (n = 117) with unclear randomisation and allocation concealment. The results were measured at the end of treatment (two weeks). There is a concern that the results are not sustained. The outcome was not measured using a validated tool. ¹⁰Downgraded to low quality due to limitations in study methodology and imprecision. Results are from one small study (n = 117) with unclear randomisation and allocation concealment. There is a small effect size with large confidence intervals. The outcome was not measured using a validated tool.

Summary of findings for the main comparison. Short‐course oral corticosteroids compared with placebo/no treatment for chronic rhinosinusitis

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Table 1. Summary of the most commonly reported side effects of systemic steroids

System	Adverse events	Notes
Musculoskeletal	Osteoporosis	Largely limited to long‐term use Significantly increased risk of fractures with prolonged use
Musculoskeletal	Osteonecrosis	Rare, appears to be dose‐dependent
Endocrine	Hyperglycaemia	Common; dose‐dependent, usually reversible
Cardiovascular	Hypertension	Common; dose‐dependent, usually reversible
Dermatological	Striae, bruising	Dose‐dependent; occurs after > 1 month usage
Ophthalmological	Cataracts	Irreversible; largely related to long‐term usage
Ophthalmological	Glaucoma	High risk with pre‐existing disease
Gastrointestinal tract	Peptic ulceration	Increased risk largely due to concomitant NSAIDs
Psychological	Psychosis	Common; increased risk with dosages > 40 mg/day
References: Da Silva 2006; Naber 1996; Stanbury 1998 NSAIDs: non‐steroidal anti‐inflammatory drugs

Table 1. Summary of the most commonly reported side effects of systemic steroids

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Comparison 1. Oral steroids versus no treatment/placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Disease‐specific health‐related quality of life ‐ no pooling (2 to 3 weeks) Show forest plot	2		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1 Severity score of RSOM	1	40	Std. Mean Difference (IV, Fixed, 95% CI)	‐1.24 [‐1.92, ‐0.56]
1.2 Mini‐RQLQ	1	58	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.79 [‐1.32, ‐0.25]
2 Disease‐specific health‐related quality of life ‐ RQLQ (3 to 6 months) Show forest plot	1	50	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.59 [‐1.16, ‐0.02]

3 Disease severity (patient‐reported total symptom score) Show forest plot	4		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.1 Final value (2 to 3 weeks)	3		Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Change from baseline (2 to 3 weeks)	1		Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Final value (3 to 6 months)	1		Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 Change from baseline (3 to 6 months)	1		Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Individual symptoms: nasal obstruction (final value) Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	‐4.5 [‐6.42, ‐2.58]

5 Individual symptoms: nasal obstruction (change from baseline) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 Change from baseline (2 to 3 weeks)	1	114	Mean Difference (IV, Fixed, 95% CI)	‐38.02 [‐48.16, ‐27.88]
5.2 Change from baseline (3 to 6 months)	1	114	Mean Difference (IV, Fixed, 95% CI)	0.90 [‐8.97, 10.77]
6 Individual symptoms: nasal discharge (final value) Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	‐4.7 [‐6.79, ‐2.61]

7 Individual symptoms: nasal discharge (change from baseline) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 2 to 3 weeks	1	114	Mean Difference (IV, Fixed, 95% CI)	‐55.57 [‐69.23, ‐41.91]
7.2 3 to 6 months	1	114	Mean Difference (IV, Fixed, 95% CI)	‐1.83 [‐13.46, 9.81]
8 Individual symptoms: facial pressure (final value) Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	‐3.7 [‐6.02, ‐1.38]

9 Individual symptoms: facial pressure (change from baseline) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

9.1 2 to 3 weeks	1	114	Mean Difference (IV, Fixed, 95% CI)	‐30.66 [‐46.28, ‐15.04]
9.2 3 to 6 months	1	114	Mean Difference (IV, Fixed, 95% CI)	0.60 [‐12.56, 13.76]
10 Individual symptoms: loss of sense of smell (final value) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10.1 2 to 3 weeks	2	80	Mean Difference (IV, Fixed, 95% CI)	‐2.79 [‐4.11, ‐1.47]
10.2 3 to 6 months	1	50	Mean Difference (IV, Fixed, 95% CI)	‐1.20 [‐2.68, 0.28]
11 Individual symptoms: loss of sense of smell (change from baseline) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

11.1 2 to 3 weeks (after treatment)	1	114	Mean Difference (IV, Fixed, 95% CI)	‐44.35 [‐57.31, ‐31.39]
11.2 3 to 6 months	1	114	Mean Difference (IV, Fixed, 95% CI)	‐15.05 [‐29.69, ‐0.41]
12 Adverse events ‐ significant mood disturbance Show forest plot	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	2.5 [0.55, 11.41]

13 Adverse events ‐ gastrointestinal disturbance Show forest plot	3	187	Risk Ratio (M‐H, Fixed, 95% CI)	3.45 [1.11, 10.78]

14 Adverse events ‐ insomnia Show forest plot	3	187	Risk Ratio (M‐H, Fixed, 95% CI)	3.63 [1.10, 11.95]

15 Endoscopy score ‐ nasal polyps (final value) Show forest plot	4		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

15.1 2 to 3 weeks	4	253	Mean Difference (IV, Fixed, 95% CI)	‐0.76 [‐0.92, ‐0.61]
15.2 3 to 6 months	1	50	Mean Difference (IV, Fixed, 95% CI)	‐0.25 [‐0.62, 0.12]
16 Endoscopy score ‐ nasal polyps score (change from baseline) Show forest plot	2		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only

16.1 2 to 3 weeks	2	146	Std. Mean Difference (IV, Fixed, 95% CI)	‐1.77 [‐2.16, ‐1.38]
16.2 3 to 6 months	1	114	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.52 [‐0.90, ‐0.14]

Comparison 1. Oral steroids versus no treatment/placebo

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Short‐course oral steroids alone for chronic rhinosinusitis

Appendices

Appendix 1. Search strategies

Appendix 2. Data extraction form

Appendix 3. EPOS 2012 diagnostic criteria

Appendix 4. Nasal polyp grading scales

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Appendices

Appendix 1. Search strategies

Appendix 2. Data extraction form

Appendix 3. EPOS 2012 diagnostic criteria

Appendix 4. Nasal polyp grading scales

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